BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIATURE

    MDR report key: 2701407 · Received August 13, 2012

    Report

    Report Number
    1218087-2012-00054
    Event Type
    Malfunction
    Date Received
    August 13, 2012
    Manufacturer
    PACE MEDICAL, INC
    Product Code
    DTE
    PMA / PMN Number
    K870323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED THE DEVICE STATING THAT THE PREVIOUS REPAIR DID NOT SOLVE THE PROBLEM. HOSPITAL'S EBME DEPARTMENT SUSPECTS USER ERROR AS THEY FOUND NO FAULT. THE DEVICE WAS ANALYZED. NO FAULT WAS FOUND. THE DEVICE WAS RE-CALIBRATED AND FINAL TESTED. ALL TESTS WERE PASSED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. REASON FOR COMPLAINT: USER ERROR.

    Description of Event or Problem · 1

    PACE MEDICAL WAS NOTIFIED ON (B)(6) 2011 BY (B)(6) VIA LETTER THAT UNIT HAD A FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIATURE TEMPORARY CARDIAC PACEMAKER DTE PACE MEDICAL, INC EV4543 NA

    Patients

    Seq Age Sex Outcome Treatment
    1